It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

NO PROCESS

402(a)(4), 801(a)(3); ADULTERATION

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure
to file a scheduled process demonstrates that the product is not being manufactured under the mandatory
provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under
insanitary conditions whereby it may have been rendered injurious to health.